Scrawled on a single sheet of paper, an FDA inspection form appears to back whistleblower allegations that pharmaceutical giant Merck committed fraud to convince the government its mumps vaccine still works.

The bigger question appears to be: Why didn’t the FDA do anything about it?

The document below, obtained by Age of Autism under a Freedom of Information Act request, is dated August 6, 2001. The FDA inspector who showed up that day at Merck’s vaccine laboratory in West Point, Pennsylvania, noted “raw data is being changed with no justifications.”

“Spreadsheets used to determine questionable results and retesting clinical samples for [redacted] has not been validated,” the inspector adds.

Faking data to hide the real lab results is at the heart of the claim by two former Merck scientists, who filed suit under the federal whistleblower statute. Virologists Stephen A. Krahling and Joan A. Wlochowski say they witnessed the fraud firsthand when they worked at the Merck vaccine laboratory in West Point between 1999 and 2002, and were pressured to participate.

Ironically, the fact the FDA investigated after Krahling triggered the inspection is being cited by the drugmaker in its effort to dismiss the suit.

“They [the whistleblowers] are asking the court to muscle the FDA out of the way and decide on the science,” Merck attorney Eric Sitarchuk told a federal judge last week, according to a report by Law360. “It's precisely that problem that's why [a whistleblower] case can't be based on the alleged falsity of a label” describing the safety and efficacy of the vaccine.

The suit was unsealed in federal district court in Philadelphia last summer, soon after the Justice Department, which had been studying the allegations for more than a year, declined to intervene on the whistleblowers’ side. As we reported then, the alleged fraud was a multi-year effort to hide the fact that the mumps vaccine is no longer anywhere near as effective as Merck claims and may have led to scattered mumps outbreaks around the country.

The fraud was dubbed Protocol 007 and widely known and approved within the company’s vaccine division, according to Krahling and Wlochowski.

In federal court last week, a lawyer for the whistleblowers argued that Merck’s deception meant the Centers for Disease Control and Prevention spent hundreds of millions in taxpayer dollars on a vaccine that didn’t work as promised. The mumps vaccine is a component of Merck’s MMR-II – mumps, measles and rubella – shot. It is the only mumps vaccine currently available in the United States.

Merck could face huge financial penalties and even lose its U.S. license to manufacture the vaccine if found guilty.

“Why would Merck go to the extreme extent of falsifying and manipulating the data it they didn't themselves believe this would have affected the government's purchase?” asked Gordon Schnell, an attorney for the whistleblowers. “All we need to show is that Merck concealed information to keep the government purchasing hundred of millions of dollars of the vaccine.”

Merck says the suit is without merit and the mumps vaccine is safe and effective, but it has not specifically denied its employees engaged in the conduct alleged by the whistleblowers – arguing instead that they have no standing to sue. That may be because the documentary evidence is quite strong, including an instruction sheet on how to commit the fraud, allegedly written and distributed internally by the company scientist in charge of the project: “Objective: Identify a mumps neutralization assay format [testing procedure] that permits measurement of a greater than or equal to 95% seroconversion rate in MMRII vaccines.”

Protecting 95 percent of those who get the shot against mumps is the standard required for continued government approval of the vaccine. According to the whistleblowers, the only goal all along was to reach that number in whatever way possible.

“Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding,” according to the lawsuit. “In performing this testing, Merck’s objective was to report efficacy of 95 percent or higher regardless of the vaccine’s true efficacy. The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results. … Krahling and Wlochowski participated on the Merck team that conducted this testing and witnessed firsthand the fraud in which Merck engaged to reach its desired results. Merck internally referred to the testing as Protocol 007.”

Krahling had alerted the agency to what he said was a frantic scene: his bosses were changing test results that showed the mumps vaccine wasn’t working; destroying garbage-bags full of evidence to keep the fraud from being exposed; and lying to FDA regulators who came to the lab.

The fact the FDA investigated, but took no apparent action in the face of such evidence, raises another question: What didn’t the FDA do, and why didn’t it do it? Strangely, the agency appears to have come back to the plant several times after it was originally summoned by Krahling, but focused instead on comparatively innocuous production violations.

“Merck & Co. Inc. has been cited by the U.S. Food and Drug Administration for failing to follow proper sterility and testing procedures at its vaccine plant in West Point, Montgomery County, according to federal inspection reports,” Linda Lloyd reported in the Philadelphia Inquirer on January 9, 2002, five months after the visit triggered by Krahling.

“U.S. regulators, who inspected the plant in August and again during the fall, found many quality-control problems, including leaking ampules during drug packaging, flawed documentation for rejected drug batches, and workers who did not follow proper sterility procedures, those records say.”

The original August 2001 inspection was clearly the one triggered by Krahling that led to his whistleblower suit. The article notes, “FDA inspectors visited Merck's West Point plant on Aug. 6 and returned several times between Aug. 27 and Oct. 29.”

The article quotes the handwritten findings that raw data had been changed in lab notebooks and questionable spreadsheet results had not been validated. The FDA’s actions, however, focused on quality control issues that led the plant to “voluntarily interrupt” its production lines while they were being addressed. Merck spokesman Christopher Loder told the Inquirer the problems had been identified during a “routine” inspection, which doesn’t match the events surrounding the August 6 FDA visit after being alerted by Krahling.

The scenario raises the possibility that the agency essentially ignored the deeper problem – evidence that one of the vaccines being manufactured at the plant simply didn’t work as advertised, and fraud was being committed to hide the truth – and instead slapped the firm with violations that could be described as “routine.”

Even so, the “voluntary” production stoppage may have been behind shortages in Merck vaccines that developed in 2002 and 2003, according to the whistleblowers.

The suit says testing on the mumps vaccine began in 1999, led by Senior Investigator David Krah and his second-in-command, Mary Yagodich. Merck’s Executive Director of Vaccine Research, Alan Shaw, approved the testing methodology, the suit says. (The FDA notice above about test results being "changed with no justifications" is addressed to Shaw.)

Krahling said he complained about the fraud to Emilio Emini, Vice President of Merck’s Vaccine Research Division, and brought “actual testing samples and plaque counting sheets to demonstrate to Emini the fraudulent data that Krah was directing. Emini agreed that Krah had falsified the data,” the suit said, but defended some aspects of the work.

“Emini promised to conduct an ‘internal audit’ of the mumps testing. … Emini ordered Krahling not to call the FDA. Immediately after the meeting [a Human Resources representative] approached Krahling and again threatened that he would be put in jail if he contacted the FDA.”

Shortly thereafter, Krahling was transferred to another lab, and soon left the company; Wlochowski was also transferred and left the next year. (In 2005, Emini became Executive Vice President of Vaccine Research and Development at Wyeth Pharmaceuticals. He is now Senior Vice President and Chief Scientific Officer of Vaccine Research at Pfizer.)

At the court hearing last week, a lawyer for the U.S. Justice Department told the judge that the fact the department had not intervened on behalf of the whistleblowers should not be used as reason to dismiss the case. She rejected Merck’s claim that private citizens shouldn’t be allowed to bring a whistleblower suit over fraud against the FDA.

The Justice Department’s continued interest in the case, contrasted with the apparent lack of action by the FDA when alerted to the alleged fraud, raises the specter of a potential conflict between departments in the Executive Branch. It might explain why Justice did not initially intervene but seems to be quite public in keeping the option open. Most whistleblower suits that succeed eventually gain Justice Department backing, people familiar with the process say.

One anomaly in the FDA’s August 6 inspection form stands out: the signature line. Two FDA employees are listed. The first was unsurprising, Debra Bennett, a field-based CSO (or consumer safety officer), the FDA staff charged with inspections and investigations. The second seems more unusual: Kathryn Carbone, a senior scientist from the FDA’s Office of Vaccine Research and Review. Back in August 2001, Carbone would have been well aware of the political dynamite involved in allegations of scientific fraud involving the MMR vaccine. On March 8, 2001, just a few months before, she was a panelist in the Institute of Medicine’s safety review on “MMR and Autism” and was followed on the agenda by none other than Dr. Andrew Wakefield.

Meanwhile, as we reported in June, the National Institutes of Health, like the FDA and CDC part of the Department of Health and Human Services, appears to have tipped its hand over concern about the mumps vaccine. Just as the whistleblower suit was unsealed last year, health officials awarded almost $2 million to a research team at the University of Georgia.

The goal: Find a much better mumps vaccine, in a hurry. “The fact that outbreaks had occurred in populations with over 95% coverage of two-dose [mumps] vaccine strongly suggests that the current vaccine is not effective,” according to project information filed by Biao He, a researcher at the University of Georgia who received the $1.8 million grant.

We also noted that scattered mumps outbreaks this year – possibly underreported by the CDC – are reinforcing longstanding concern that Merck’s mumps vaccine is failing far more often than it should. The outbreaks appear to be following a three-to-four-year cycle in which a new cohort of immunologically susceptible persons is exposed but lacks full vaccine protection.

The current outbreak appears centered in college-age students. While mumps is generally benign when contracted in childhood, it can be much more serious when caught later. In males it can be excruciatingly painful and even lead to sterility.

If vaccine failures are involved in the current outbreak, that would also undercut Merck’s statement that there is no safety issue involved with the alleged fraud.

--Dan Olmsted and Mark Blaxill are editors of AgeOfAutism.com and co-authors of “The Age of Autism – Mercury, Medicine, and a Man-made Epidemic.”

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Just to clarify - please note that the beginning of what I just posted today on the mumps outbreak at Ohio State University, except for the last paragraph with my comments, is a direct quote from the article.

He said those infected include 23 students and a staff member at the university in Columbus, Ohio, and four other people with connections to students or links to the community.

The spokesman, Jose Rodriguez, said all but one had received at least one dose of the mumps vaccine...

Dr. Gregory Wallace, a CDC expert on mumps and other communicable diseases, said people who are vaccinated may still get the mumps, but typically have fewer and less severe complications than those who are not."

Nothing about the fact that Merck is involved in a whistleblower law suit brought by their own virologists claiming that the company deliberately hid knowledge that the mumps portion of the MMR isn't even close to the efficacy rate the company quoted upon sale of the vaccine to the American government and people.

"....A few weeks after that, on October 7th, to coincide with World Mental Health day (October 10th), Newsweek hit the streets featuring a depressed teenager on the front cover and a strapline [advertising slogan] 'Teen Depression: 3 million kids suffer from it. What you can do.' The message inside was that Prozac was already being marketed for children and Paxil and Zoloft were about to be. What you can do – is get children on Prozac, Paxil and Zoloft.

Three days later, on October 10th, World Mental Health Day, and the 40th anniversary of the passage of the 1962 amendments to the Food and Drugs Act, FDA sent GSK a letter saying Paxil was approvable for kids.

Among other things, the letter notes that GSK had already told FDA that Study 329 showed that Paxil doesn’t work for depressed children. FDA were happy to go along with GSK’s suggestion that this should not be mentioned in the labeling of the drug. Given that the Study 329 publication majored on how effective Paxil was, it would have been inconvenient if the label said otherwise...."

Linda and no vac- absolutely we should be going after schoolboards, governors for damages. We should also have some kind of list/website naming corrupt journalists who are paid pharma marketing writers- definitely they need to be exposed, shamed and ridiculed publicly. A list could be present here on this site or even on independent sites.

Enabler is too passive to describe what these journalists are doing. They are accomplices and direct beneficiaries of the spoils. In some cases, there are kickbacks and perks. In others, publishing propaganda without researching the facts or hiding the facts regarding vaccination, is a condition of employment. Either way, they benefit by aiding the crime of misleading the public, by denying the public informed consent, by deliberately tricking the public into believing that they are informed when in fact, they are not.

"This sounds like a commercial but I have to say that GSK’s Advair (inhaled steroid combined with a bronchodilator) has given me five years of complete disease control.

Asthma provides very compelling evidence to show how step-change and incremental advances by the pharma industry deliver spectacular benefits to the patient.”

Is by "One unexpected comment I received was from a former colleague from Pfizer."

..and this quote

"My guess is that there are those that will deem Advair to be not a lot different from theophylline in terms of being a breakthrough for asthma patients. However, oftentimes innovation does not occur in major leaps. Rather, gradual improvements are made over time."

"The 2001 product launch of the asthma drug Advair (fluticasone/salmeterol) was a lavish, Las Vegas affair.

Using images of a slot machine to illustrate their message, top GlaxoSmithKline executives took the stage in front of thousands of assembled sales reps. "There are people in this room who are going to make an ungodly sum of money selling Advair," one executive told the group.

He was right."

...and safety , ethics and morals went out the door.

"According to the U.S. Centers for Disease Control and Prevention, asthma deaths in the U.S. have been declining since the late 1990s. In 2009, there were 3,388 asthma deaths.

The problem appears to be the long-acting beta-agonist salmeterol that is one component of Advair."

"But long-acting beta-agonists have been linked to 1,900 asthma deaths from 2004 through 2011..."

"In 2008 a different analysis by a researcher with the U.S. Food and Drug Administration estimated the drugs contributed to 14,000 asthma deaths from 1994 through 2007. Advair, approved in 2000, is by far the biggest seller."

"Marcus Faulk of Louisville, Ala. also had a bad reaction to Advair or to Serevent, one of the two drugs it comprises. He started out on Serevent and “said that every time he took the medicine it made him feel worse,” says his aunt, Annette Glanton. A few weeks after Faulk tried Advair, he collapsed on the floor of a relative’s home, late on the night of Jan. 6, 2003. Just 20 years old, he was dead by the time the ambulance pulled up to the hospital, his Serevent inhaler still clutched in one hand. Three years later his father, Earl Faulk, a truck driver, still can’t talk about it without breaking down and sobbing. He has sued Advair’s maker, GlaxoSmithkline. It says the drugs’ benefits outweigh their risks, and, in court filings, denies the charges."

"I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asia."

"This sounds like a commercial but I have to say that GSK’s Advair (inhaled steroid combined with a bronchodilator) has given me five years of complete disease control.

Asthma provides very compelling evidence to show how step-change and incremental advances by the pharma industry deliver spectacular benefits to the patient.”

"My guess is that there are those that will deem Advair to be not a lot different from theophylline in terms of being a breakthrough for asthma patients. However, oftentimes innovation does not occur in major leaps. Rather, gradual improvements are made over time. "

"But every day journalists get away with making claims that vaccines are completely safe and effective, that vaccines do not cause autism or any other health problems, claims that contradict the vaccine manufacturers' product labels, the VAERS and the US and foreign court settlements. Why doesn't the FDA come down on these liars the way that they come down on food and supplement manufacturers? "

Agree, we should also go after the corrupt journalists. All those who make claims about vaccine safety are paid by pharma cartels. All major media outlets have at least one brainwashed and paid by pharma an useful idiot, who will write and sign his name on any piece of pharma lie and propaganda. And we should go after pseudoscientists, who manufacture and publish falsified data for grants and support from pharma cartels. We should expose them to public shame, ridicule and contempt.

The FDA is itself so corrupt that I would not expect justice or honesty from them. They are servants of pharma cartels. Nonetheless, it may be wise to resport to the FDA that a journalist X is misrespresenting claims about a drug or vaccine, for the record. We should simultaneously send the info all over the internet.

It means , we should go after the enablers of vaccine crime against American children.

I would like to add that journalists also get away with publishing misleading claims about vaccine safety studies that are not just interpretive differences. They are outright easily verifiable lies, told to the public, for the purpose of aiding the sales of pharmaceutical products under false pretenses.

If a food or supplement manufacturer makes a claim that a product provides some health benefit that is not true, or not proven, the FDA comes down on them like a ton of bricks. But every day journalists get away with making claims that vaccines are completely safe and effective, that vaccines do not cause autism or any other health problems, claims that contradict the vaccine manufacturers' product labels, the VAERS and the US and foreign court settlements. Why doesn't the FDA come down on these liars the way that they come down on food and supplement manufacturers?

Lisa,
I agree. At this point we should go legally after the school districts and the governors, as they are ultimately responsible for pushing toxic vacs on American children. Hence they are directly responsible for crippling millions of children. They may claim, that parents who want to vaccinate demand that other children at school be also vaccinated, which is conceivable. In this situation I propose that there be two types of public schools: 1) for vaccinated and 2) for not vaccinated.... for a time being. After 10 years, when it will become clear that unvac children are much smarter and healthier than those vaccinated, I am sure that most parents will choose not to vaccinate their children.

FDA's default position is to always believe the word of a vaccine manufacturer's management, over any employees.

They did exactly the same thing within their own organisation, in 1975, when the Swine Flu vaccine came out. Dr Anthony J Morris, who was FDA's OWN employee, tasked with testing the vaccine and the virus, said that the virus was just an ordinary pig virus and not especially pathogenic - that it had not spread beyond one person, and that the vaccine was highly dangerous.

His bosses said he was wrong, and told him to shut his mouth. He refused, and appeared on the Phil Donohue show, did public talks, and gave articles to the Washington Post, so was fired for insubordination.

That triggered a 7 year long court case, which Dr Morris won, but the world didn't hear much about that, did they?

FDA only takes anything "seriously" when it's impossible to ignore, and most of the time, they respond with limp wet noodles.

But the FDA, when it comes to non-pharmaceuticals, get swat teams, storm the facilities like it's some terrorist raid, and do everything possible to put the staff out of business, and get the licenses taken of doctors.

It's called, "selling your souls" to the highest bidder. Why? Because there is a revolving door policy whereby FDA/CDC staff get cushy jobs in the pharmaceutical industry that they spend so much time protecting, when they leave FDA or CDC. Witness Gerberding's current appointment.

Just review the scroll of names from the past who hopped from FDA or CDC to vaccine manufacturing companies, drug companies.... and ask why it is no-one seems to join the dots!

We need a new flu shot each and every year but the same mumps virus has been used in vaccines for over 40 years as it never changes.

They are now trying to make a "more contagious H7N9 virus" ...in the lab... so they can tell the WHO to declare a pandemic so western nations will be required to pay for a billion doses whether they are used or not...

Just a conjecture here- We are always told that mumps disease in adults may result in inflammation of the testes in males, resulting in sterility. Now, lets suppose that back in the days when gamma globulin was one of the few medications that mainstream medicine had to throw at disease , some young boys were given gamma globulin when they had measles and the mercury in the gamma globulin caused them inflammation of the testes, with later sterility. Now suppose that after this, the mumps disease was accused of causing the sterility, resulting in even more use of gamma globulin for mumps disease. So, does anyone here have the ability to check whether inflammation of the testes with mumps was ever reported in pre gamma globulin days?

The reason I think that we need an Edward Snowden is that these are all legitimate reasons to file an injunction against our school districts preventing them from requiring that children be vaccinated in order to enter the schools. Every piece of evidence that says we're being lied to about the program is in my opinion a legal basis for making the program voluntary at the very least. Heck, I think we even have enough information from the CDC, in their report about vaccines not being safely stored in doctors' offices, to be able to sue our school districts. We already know we can't sue after the fact, when the harm has already been done, but what about before the fact? All of this evidence of fraud -- and I'm sure there's plenty more where it came from -- adds up to what I think would be a solid legal case against those who are forcing us into submission.

And one wonders how it is so easy for the "science-based" crowd to accept anything that the pharmaceutical industry says. We have verifiable evidence of corruption and cover-up, and clear evidence that the agencies used to police the industry are complacent in letting them continue their corruption.

I don't think we need any Edward Snowdens. I am sure we've had this discussion before over Julian Assange and Bradley Wiggins. Our problem is not shortage of evidence of grand and manifold malfeasance, it is actually that every agency is so corrupt that it is impossible to get action. Julian Assange's leaks ended up being managed by the extra-vile and disgusting New York Times and UK Guardian newspapers, who wouldn't lift a finger to help us.

Maybe the very fact of legal jeopardy helps to make it a news story but only because the mainstream media and their cronies want it to.

Thanks for keeping on this, this one really stinks. The link to the whistle blower complaint is below, I would urge folks to read it. It's long, but well written in relatively plain English considering the subject. They name names and walk step by step through the deception, explaining why the fraud was required, what tests failed, the methods used to falsify the test data, and who told them to do it.

Another interesting aspect is that one gets the impression that this type of thing is not unusual at Merck but engrained in their corporate culture. Not surprising based on their past history.

I really think we need some Edward Snowdens to come forward and volunteer to go to work undercover for Merck, Pfiser, et al., in some benign job like "filing." It probably would not take more than a few months, just as it did with Snowden, to uncover crimes against humanity, and leak them to online media like Age of Autism. I know. I know. NSA will be knocking out my door as soon as I press "Post." I uttered the words Snowden, undercover and leak in the same breath. I am a dissident and a traitor and a threat to our national security.

Seriously, there is very serious stuff going on in this country right now. Very scary.

"The fact the FDA investigated, but took no apparent action in the face of such evidence, raises another question: What didn’t the FDA do, and why didn’t it do it?"

It should surprise no one the FDA "didn't do anything" in the face of such evidence. Unfortunately, there are far too many .. life-long career bureaucrats .. entrenched in what have become "sham" federal regulatory agencies .. the FDA being only just one .. who cannot pursue evidence of fraud or corruption because to do so .. they would put their own professional reputations and careers in jeopardy.

The greater problem is the political process that is supposed to oversee these sham regulatory agencies is just as compromised (corrupt) .. by the far too many life-long career politicians .. who ... by reason of their "seniority" .. serve as members of the committees most likely to benefit from the lucrative campaign contributions of the industries they are charged with regulating.

And .. so .. we can expect Merck to avoid any real consequences . from either the FDA or the Justice Department .. on what the evidence shows to be an ongoing criminal conspiracy of fraud that has been perpetrated upon the people of the United States.

Is it any wonder the "known and unknown" persons who were federally indicted along with Poul Thorsen remain "in the wind"?